Abstract：
BACKGROUND: Daylight photodynamic therapy (DL-PDT) has become one of the most effective treatments for the resolution of actinic keratosis (AK) of Olsen grade 1 and 2. Generally, PDT it is carried out in a clinic setting, which involves the patient\'s and their caregivers commuting to the hospital as well as a significant use of resources to carry it out within the clinic setting.
OBJECTIVE: To determine the efficacy and safety of a home-based treatment of AK with DL-PDT with the BF-200 ALA gel compared to a clinic-based setting.
METHODS: The study was performed as a randomized, single-center, non-inferiority clinical trial with two parallel groups. 9 patients received one clinic-based DL-PDT (group 1) and 11 patients received one session of home-based DL-PDT (group 2). The primary endpoints were the mean AK clearance per patient and the total AK lesion clearance rate 12 weeks after treatment. The secondary endpoints were the number of remaining AKs and new AKs appearing in the treatment field 12 weeks after one PDT session. The pain during and 24 h after PDT as well as the local skin reactions were also assessed.
RESULTS: The overall reduction of AK lesions per patient was similar in both groups with one PDT session. An overall AK clearance per patient of 10 ± 4.33 for group 1 versus 9.73 ± 2.9 for group 2 without statistically significant differences (p = 0.868). Regarding the clearance rate, although it was slightly higher in group 2 (71.58 ± 22.51 vs 82.1 ± 11.13), the analysis did not show statistically significant differences. The mild pain recorded during the treatment course and the mild local skin reactions were similar in both groups. Patient satisfaction was high for both groups without statistically significant differences.
CONCLUSIONS: Self-performed home-based DL-PDT with BF-200 ALA gel is as effective as the one performed in a clinic-based setting, with a comparable safety profile, high levels of patient satisfaction and with advantages for the patients and their caregivers that can enhance patient´s adherence to the treatment.
OBJECTIVE: To determine the efficacy and safety of a home-based treatment of AK with DL-PDT with the BF-200 ALA gel compared to a clinic-based setting.
METHODS: The study was performed as a randomized, single-center, non-inferiority clinical trial with two parallel groups. 9 patients received one clinic-based DL-PDT (group 1) and 11 patients received one session of home-based DL-PDT (group 2). The primary endpoints were the mean AK clearance per patient and the total AK lesion clearance rate 12 weeks after treatment. The secondary endpoints were the number of remaining AKs and new AKs appearing in the treatment field 12 weeks after one PDT session. The pain during and 24 h after PDT as well as the local skin reactions were also assessed.
RESULTS: The overall reduction of AK lesions per patient was similar in both groups with one PDT session. An overall AK clearance per patient of 10 ± 4.33 for group 1 versus 9.73 ± 2.9 for group 2 without statistically significant differences (p = 0.868). Regarding the clearance rate, although it was slightly higher in group 2 (71.58 ± 22.51 vs 82.1 ± 11.13), the analysis did not show statistically significant differences. The mild pain recorded during the treatment course and the mild local skin reactions were similar in both groups. Patient satisfaction was high for both groups without statistically significant differences.
CONCLUSIONS: Self-performed home-based DL-PDT with BF-200 ALA gel is as effective as the one performed in a clinic-based setting, with a comparable safety profile, high levels of patient satisfaction and with advantages for the patients and their caregivers that can enhance patient´s adherence to the treatment.
摘要：
背景：日光光动力疗法（DL-PDT）已成为解决Olsen1级和2级光化性角化病（AK）的最有效治疗方法之一。一般来说,PDT是在诊所进行的，这涉及患者和他们的照顾者通勤到医院，以及大量使用资源在诊所环境中进行。
目的：为了确定BF-200ALA凝胶DL-PDT治疗AK的疗效和安全性，与基于临床的治疗相比。
方法：本研究以随机，单中心,两个平行组的非劣效性临床试验。9名患者接受了一次基于临床的DL-PDT（第1组），11名患者接受了一次基于家庭的DL-PDT（第2组）。主要终点是每位患者的平均AK清除率和治疗后12周的总AK病变清除率。次要终点是一个PDT疗程后12周出现在治疗领域的剩余AK和新AK的数量。还评估了PDT期间和24小时后的疼痛以及局部皮肤反应。
结果：两组患者一次PDT治疗时，每位患者的AK病变总体减少相似。第1组每位患者的总AK清除率为10±4.33，第2组为9.73±2.9，没有统计学上的显着差异（p=0.868）。关于清关率，尽管在第2组中稍高（71.58±22.51vs82.1±11.13），分析显示差异无统计学意义.两组治疗过程中记录的轻度疼痛和轻度局部皮肤反应相似。两组患者满意度均较高，无统计学差异。
结论：用BF-200ALA凝胶自行进行的基于家庭的DL-PDT与在基于临床的环境中进行的DL-PDT一样有效，具有可比的安全性，高水平的患者满意度，并为患者和他们的照顾者的优势，可以提高患者对治疗的依从性。
目的：为了确定BF-200ALA凝胶DL-PDT治疗AK的疗效和安全性，与基于临床的治疗相比。
方法：本研究以随机，单中心,两个平行组的非劣效性临床试验。9名患者接受了一次基于临床的DL-PDT（第1组），11名患者接受了一次基于家庭的DL-PDT（第2组）。主要终点是每位患者的平均AK清除率和治疗后12周的总AK病变清除率。次要终点是一个PDT疗程后12周出现在治疗领域的剩余AK和新AK的数量。还评估了PDT期间和24小时后的疼痛以及局部皮肤反应。
结果：两组患者一次PDT治疗时，每位患者的AK病变总体减少相似。第1组每位患者的总AK清除率为10±4.33，第2组为9.73±2.9，没有统计学上的显着差异（p=0.868）。关于清关率，尽管在第2组中稍高（71.58±22.51vs82.1±11.13），分析显示差异无统计学意义.两组治疗过程中记录的轻度疼痛和轻度局部皮肤反应相似。两组患者满意度均较高，无统计学差异。
结论：用BF-200ALA凝胶自行进行的基于家庭的DL-PDT与在基于临床的环境中进行的DL-PDT一样有效，具有可比的安全性，高水平的患者满意度，并为患者和他们的照顾者的优势，可以提高患者对治疗的依从性。
